Generic Medicine Info
May be taken with or without food.
Hypersensitivity. Concomitant use with drugs known to prolong QT interval and are metabolised by CYP3A4 isoenzyme (e.g. cisapride, astemizole, amiodarone, erythromycin, pimozide, quinidine). Concomitant use with terfenadine in patients receiving fluconazole at multiple doses of ≥400 mg daily.
Special Precautions
Patient with proarrhythmic condition (e.g. congenital or documented acquired QT prolongation, structural heart disease, sinus bradycardia, existing symptomatic arrhythmias, electrolyte disturbances [e.g. hypokalaemia, hypomagnesaemia, hypocalcaemia]), serious underlying disease (e.g. AIDS, cancer). Renal and hepatic impairment. Neonates and children. Pregnancy and lactation. Patient Counselling This drug may cause dizziness or seizures, if affected, do not drive or operate machinery. Monitoring Parameters Perform culture and susceptibility tests; consult local institutional recommendations before treatment initiation due to drug resistance risks. Monitor LFTs (e.g. AST, ALT, alkaline phosphatase), renal function and serum K periodically. Assess for rash, abdominal pain, and signs and symptoms of hepatic injury.
Adverse Reactions
Significant: Adrenal insufficiency (reversible). Rarely, anaphylactic reactions, QT prolongation on ECG, torsades de pointes. Blood and lymphatic system disorders: Anaemia. Ear and labyrinth disorders: Vertigo. Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal pain, taste perversion, constipation, dry mouth, flatulence, dyspepsia. General disorders and administration site conditions: Malaise, fatigue, fever, asthenia. Investigations: Increased ALT, AST or alkaline phosphatase. Metabolism and nutrition disorders: Decreased appetite. Musculoskeletal and connective tissue disorders: Myalgia. Nervous system disorders: Headache, dizziness, seizures, paraesthesia. Psychiatric disorders: Insomnia, somnolence. Skin and subcutaneous tissue disorders: Increased sweating, rash, fixed drug eruption, alopecia, pruritus, urticaria.
Potentially Fatal: Rarely, serious hepatotoxicity, severe cutaneous adverse reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms).
ROUTE(S) : PO: C For a single dose of 150 mg for vaginal candidiasis.
ROUTE(S) : PO: D For use in indications other than vaginal candidiasis.
Drug Interactions
Increased plasma concentrations with hydrochlorothiazide. Decreased serum concentrations with rifampicin. May increase the plasma concentrations of drugs metabolised by CYP3A4, CYP2C9, and CYP2C19 (e.g. halofantrine, amitriptyline, nortriptyline, midazolam, triazolam, amlodipine, verapamil, felodipine, carbamazepine, celecoxib, flurbiprofen, ciclosporin, alfentanil, fentanyl, methadone, oral estrogen-progestin contraceptives, phenytoin, rifabutin, saquinavir, glibenclamide, glipizide, tolbutamide, everolimus, tacrolimus, sirolimus, theophylline, voriconazole, zidovudine, olaparib, ivacaftor, tolvaptan, tofacitinib, abrocitinib, lemborexant, lurasidone, vincristine, vinblastine). Increased prothrombin time with anticoagulants (e.g. warfarin). Increased risk of elevated serum bilirubin and serum creatinine with cyclophosphamide. Increased risk of myopathy and rhabdomyolysis with HMG-CoA reductase inhibitors metabolised by CYP3A4 (e.g. atorvastatin, simvastatin) or CYP2C9 (e.g. fluvastatin). Inhibits the metabolism of losartan to its active metabolite. May increase the risk of CNS-related adverse effects (e.g. pseudotumour cerebri) with tretinoin.
CIMS Class
ATC Classification
J02AC01 - fluconazole ; Belongs to the class of triazole derivatives. Used in the systemic treatment of mycotic infections.
D01AC15 - fluconazole ; Belongs to the class of imidazole and triazole derivatives. Used in the topical treatment of fungal infection.
Disclaimer: This information is independently developed by CIMS based on fluconazole from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 CIMS. All rights reserved. Powered by CIMSAsia.com
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